Clinical Research Coord I

Myana; New York (NY); On-site; USD 61,000 - 75,000; Full time

Job summary

Columbia University Irving Medical Center in New York seeks a Clinical Research Coordinator I for the Pediatric Neuro Muscular Division in the Department of Neurology. The candidate will manage subject recruitment, ensure compliance with IRB and CTSC policies, and support study operations under the supervision of the PI and clinical research supervisor.

The role emphasizes meticulous documentation, coordination with sponsors and monitors, data entry in EDC systems, and contributing to

Qualifications

• Bachelor's degree or equivalent in education and experience.
• Experience with neuromuscular clinical trials.
• Must be highly organized with attention to detail.
• Strong English speaking and writing skills.

Responsibilities

• Participation in pre-study, initiation, monitoring and close-out visits.
• Submission of regulatory forms to FDA and other bodies.
• Development of SOPs and case report forms for trials.
• Recruitment and supervision of subjects with informed consent and adherence checks.
• Coordinate study activities, sponsor communications and visits.
• Document protocol deviations and corrective actions as needed.
• Data collection/management, adverse event handling, and archiving.
• Data entry and query resolution in EDC systems.
• Close-out activities, manuscript support, and final reporting.

Skills

Interpersonal communication

Written communication

Team collaboration

Self-motivation

Education

Bachelor's degree or equivalent

Tools

EPIC

MS Word

MS Excel

MS PowerPoint

Adobe Acrobat

Job description

• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule: M-F
• Building:
• Salary Range: 68,000 - 68,000

The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

Position Summary

We are seeking a Clinical Research Coordinator I for the Pediatric Neuro Muscular Division in the Department of Neurology. The candidate must be highly motivated, be interested in pediatric neuromuscular diseases, possess excellent interpersonal, communication, and writing skills as well as strong interest in academic clinical research. The candidate will be expected to establish cordial and professional rapport with children, adults and families as well as the clinical, research, and administrative teams. The ideal candidate is a team player who is also independently motivated and able to self-direct to complete tasks.

The candidate will report to the Principal Investigator (PI), Dr. Claudia Chiriboga, and the clinical research supervisor. The candidate will be responsible for subject recruitment and proper conduct of clinical studies. Additional responsibilities include maintaining compliance with existing policies and procedures at Columbia University Irving Medical Center and its Institutional Review Board (IRB) and Clinical and Translational Science Center (CTSC), that regulate and conduct clinical research.

Responsibilities

• Participation in pre-study, initiation, monitoring and close-out visits
• Submission of Investigator New Drug (IND) forms and PI initiated research protocols to FDA and other regulatory institutions in US
• Implementation of clinical trials from initiation, including participation in the development of standard operating procedures and case report forms
• Recruitment and supervision of clinical trial subjects through the following activities: informed consent, screening, and ensuring subjects adherence to safety and study compliance issues.
• Coordination and management of clinical trials, communication with sponsor and monitors, study visit coordination, sample acquisition and processing.
• Reporting and documentation of protocol deviations and exemptions as well as development and implementation of corrective action plans for review by the Principal Investigator as needed
• Data collection and management, collection of source documents, registration, and management of adverse events, filing and archiving, managing monitoring visits and managing queries.
• Participate in data entry and query resolution using Electronic Data Capture (EDC) systems
• Close-out of the clinical trial, contributing to manuscripts, audit preparation, trial completion, and communication with authorities. Other responsibilities include assisting with the final study report and completing financial obligations.
• Perform other related duties and responsibilities as assigned/requested.

Minimum Qualifications

• Requires a Bachelor's degree or equivalent in education and experience.

Preferred Qualifications

• Experience with neuromuscular clinical trials.

Other Requirements

• Must be highly organized with attention to details.
• Mastery of spoken and written English required.
• Computer skills are required including proficiency of MS Word, MS Excel, MS PowerPoint, EPIC (electronic medical record) and Adobe Acrobat.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.